Lawyer for Alabama Nursing Board Hearing – Call today to discuss your case – FDA issues rule on changes to pregnancy and lactation labeling for prescription drugs – (866) 348-2889
Women who are pregnant or breast-feeding and need to take prescription medications soon will see more detailed information regarding their prescriptions specifically for them on drug labels. The U.S. Food and Drug Administration published a final rule Dec. 3 that sets standards for how information about using medicines during pregnancy and breast-feeding is presented in the labeling of prescription drugs and biological products, according to a news release. The final rule replaces the current product letter categories – A, B, C, D and X – used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks for pregnant or breastfeeding women.
“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations,” Sandra Kweder, MD, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release. “The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk. The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”
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